Tel Aviv, Israel
A med-tech start-up with an FDA-cleared SaMD is looking for a hands-on QARA Manager. The position reports into the VP of Product and Clinical Ops and will function as the Management Representative for quality management. To succeed in this role, an intimate understanding of the SDLC and regulatory requirements for SaMD is required, and a willingness to roll up your sleeves to get the job done.
Responsibilities and Duties:
- Establish and maintain compliance with FDA QSR (21 CFR part 820), including company registration, new product submissions, establishing FDA communication/channels for compliance on medical device listings/classifications, management of a CAPA system, etc.
- Establish and maintain compliance with the EU market MDR, including CE Mark applications or self-declarations via technical files.
- Establish and maintain ISO13485 certification
- Function as the Management Representative for the company.
- Responsible for the customer complaint system and generating the monthly customer complaint report.
- Responsible for evaluating product failures and generating the evaluation report.
- Oversee the software verification and validation processes and records in the company, including the maintenance of the DHF, DMR and DHR.
- Conduct internal audits and coordinate and manage external ISO audit schedules, correspondence and closing of findings.
- Ensure compliance of labeling and advertising.
- Responsible for the Documentation Control Process and Documentation Change Control Process.
- 5-10 years experience in Quality Assurance and Regulatory Affairs for software medical devices (SaMD) - MUST
- Intimate understanding of the SDLC and quality regulations related to SaMD - MUST
- Proven hands-on experience in software verification and validation for SaMD - MUST
- Performing internal audits.
- Writing standard operating procedures and work instructions.
- Relevant academic degrees.
How to apply
email your resume and optional cover letter to: firstname.lastname@example.org